Release date: 2015-10-27
Event: 23andMe personal genetic testing was reapproved.
Two years after the FDA banned the sale of genetic disease analysis services to individual consumers, the personal genetic testing company 23andMe announced that it has re-accepted FDA approval. This revised personalised genomics service includes information on ancestral sources, health, non-medical characteristics (such as freckles, hair curl, lactose intolerance, etc.) and information on the status of the disease.
23andMe and its personal genetic testing business.
23andMe is a well-known medical service company providing personal genetic testing in the United States. In 2007, 23andMe began to provide personal genetic testing services at a price of $999. After receiving the D round of financing, the service price was directly reduced to $99. With a $99 testing service, users can get genetic information on more than 1 million sites across the genome, and analysis of this information, including predictions of 259 disease prevalence and ancestral analysis. In November 2013, the FDA requested 23andMe to suspend the provision of genetic testing services for users, allowing only ancestral testing and raw genetic data to be provided to users.
Technical level: 23andMe uses gene chip screening instead of gene sequencing.
Gene detection in 23andMe uses a gene chip screening technique that detects SNPs (single nucleotide polymorphisms) rather than gene sequencing. The specific chip used by 23andMe is based on the IlluminaHumanOmni Express-24 format chip, which can detect approximately 1 million SNPs, which are considered to be associated with the risk of disease. The life information obtained by SNP detection is much less than that of gene sequencing, so the cost of SNP detection is relatively small, which makes low-cost gene detection possible. However, with the rapid development of sequencing technology, gene sequencing will inevitably gradually replace SNP detection. We believe that the future development trend of gene detection is: gene chip-based SNP detection transition to exon sequencing, and then to genome-wide sequencing.
Regulatory level: Partial liberalization, disease risk analysis and drug allergy analysis are still not allowed.
In November 2013, the FDA called 23andMe's genetic testing and analysis services based on user safety considerations. Due to the limitations of current life science research, database monopoly, inconsistent analytical methods, and lack of genetic counseling, it is not rigorous to assess the probability of a user's illness by detecting a specific SNP. Because these problems have still not been resolved so far, 23andMe is only approved for information on ancestral, health, non-medical characteristics and disease carrying status, and is still not allowed to provide consumers with some disease risk prediction analysis and corresponding Allergic analysis of drugs, it will take a long time to fully open. As far as China's genetic testing industry is concerned, the current genetic testing market is relatively confusing, and there is a possibility of rectifying the industry in the future.
Profit model: The establishment of the database is fundamental.
Since its inception in 2006, 23andMe has attracted as many users as possible to reduce the price of DNA testing services. In the past 10 years, 23andMe has accumulated 1 million customers, and the cost of genetic testing services has brought less than $200 million in revenue to the company. This is a far cry from the company's previous investment. In fact, the database established by user genetic testing is the real value. 23andMe uses big data analysis technology to find the relationship between specific genetic traits and different diseases. These analysis results and raw data are developed by many pharmaceutical companies. The basis of the new drug, the income obtained by providing the database to the pharmaceutical company is far greater than the income of the genetic testing service, which may be the main profit model of the genetic testing company in the future.
The domestic genetic testing industry needs to be further regulated: leading enterprises benefit.
The domestic genetic testing market is broad. The main detection technologies are gene chip SNP detection and gene sequencing. The former is the main one, because the SNP detection threshold is low, and the detection cost is relatively low, which is easy to be accepted by consumers. At present, there are many genetic testing projects in various medical institutions, including disease risk analysis projects and talent analysis projects that are prohibited by the FDA. The theoretical basis of these analysis results remains to be studied, so we believe that the health sector is more likely to strengthen the industry. In terms of high-throughput gene sequencing, the government has strengthened supervision and developed a pilot list in four areas: prenatal screening and prenatal diagnosis, genetic diagnosis, tumor diagnosis and treatment, and preimplantation embryo genetic diagnosis. With the regulation and integration of the industry, we believe that a number of leading companies in genetic testing are expected to benefit, and it is recommended to focus on the diagnosis of Daan Gene and Dean. In addition, Huada Gene is preparing for the market, and Huada Gene is absolutely leading in the field of gene sequencing in China. Status needs to be focused.
Source: GF Securities
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